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510(k) K990916

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY by Stellar Bio Systems, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1999
Date Received
March 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Stellar Bio Systems, Inc.

  • K992587 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (December 22, 1999)
  • K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (April 21, 1999)
  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)

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